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Posted on in FDA

In recent months, the FDA has begun reviewing more information regarding Essure, a transcervical sterilization procedure for women. Essure is a Class III medical device that, according to the FDA, received a high level of review prior to marketing. The procedure had to be vetted through the pre-market approval process used by the FDA. This process includes reviewing data about product labeling materials and a scientific and regulatory review.

Although the FDA has received more reports of complications from women who have gone through the procedure, the federal agency still classifies the risk of adverse events as “low”. In addition to clinical studies, the FDA also reviews surveillance data sources post-market to determine how safe and effective a variety of medical devices are in practice.

Reports submitted to the FDA by consumers are helpful in identifying problems as soon as possible so that if defects or complications are a factor, other patients can be warned before being affected.

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Abbott Diabetes Care, a lead developer and manufacturer of glucose monitoring and testing systems and strips has announced that it is issuing a voluntary recall of certain lots of its FreeStyle and FreeStyle Lite Blood Glucose Testing Strips in the United States. The defective medical device recall was issued on November 27, 2013 after the company found that approximately 20 lots of the test strips may return erroneously low blood glucose readings when used with certain types of FreeStyle blood glucose meters.

When the test strips are used with the older FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter as well as the OmniPod Insulin Management System, they can return incorrectly low readings. The meters in question are older systems that have not been in production since 2010. When used with the newer FreeStyle meters such as the FreeStyle Freedom, FreeStyle Lite and FreeStyle Freedom Lite Blood Glucose Meters, test results are not affected. Testing is also unaffected on the FreStyle InsuLinx Blood Glucose Meter, as this device uses a different type of test strip.

The recall applies to FreeStyle and FreeStyle Lite test strips that expire between May 2014 and March 2015. Distributers, pharmacies, healthcare professionals and customers are being notified about the recall. Customers who have been affected by the recall have been asked to call Abbott's diabetes care customer service line at (888)-736-9869 to receive replacement test strips at no charge. For a full listing of the affected lot numbers, you may check the official recall press release on the U.S. Food and Drug Administration website.

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Posted on in FDA

The U.S. Food and Drug Administration (FDA) has issued a Class I recall of approximately 15,000 Medtronic devices used during heart procedures due to a risk of serious injury or death. The recall affects Medtronic Interventional Guidewires and ATTAIN HYBRID Guidewires. According to the FDA, these are the long, thin wires that are inserted through the artery in order to guide the placement of diagnostics or medical devices such as stents. It has been found that the polytetrafluoroethylene coating (more commonly known as Teflon) that helps the wires slide more easily through the artery can detach have the potential to block a blood vessel.

The recall effects lots of the Medtronic guidewires manufactured from April of 2013 onwards. The FDA ordered the recall in October after four serious problems were reported, including one that involved a patient who suffered cardiac arrest, but was resuscitated. The company has contacted regulators worldwide and halted any new shipments of the wires.

A Class I recall is the most serious type of recall that can be issued, and is only used in situations where use of a medical device or medication may cause serious consequences to a patient's health, or result in death. Anyone with questions regarding this recall is encouraged to visit the FDA website, or to contact the Medtronic Lifeline Technical Support line by calling (877)-526-7890, Monday through Friday from 8am to 5pm.

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Tagged in: Attorney Illinois Lawyer

Isotretinoin, also known as Accutane and one of the most effective medications for acne, is reported to cause severe birth defects to an exposed fetus. Because of this, the U.S. Food and Drug Administration created the computer-based risk management program iPledge, requiring women to review educational materials, complete tests and pledge to use two forms of birth control prior to using the drug.

However, a recent report indicates that the iPledge program been less than successful, and a small study suggests the focus be placed on more highly effective birth control methods. Dr. Eleanor Bimla Schwarz, director of the Women's Health Services Research Unit of the Center for Research on Health Care at the University of Pittsburgh and the senior author of the study, stated, “What we found is that people need a clear message about what birth control would be most effective, and currently the iPledge materials don't make it clear to most women who enroll in the program.” Schwarz also told Reuters Health that women who take isotretinoin need more information on IUDs and implants to better protect themselves from pregnancy.

While the iPledge website clearly states the high risk of severe birth defects that isotretinoin can have on an exposed fetus, earlier studies also indicate that the program and previous initiatives have had “limited or no success to prevent pregnancies among women taking the drug.” And according to the American College of Obstetricians and Gynecologists, IUDs and contraceptive implants are the most effective reversible contraceptive, and “do not require ongoing effort on the part of the user for long-term and effective use.” In an email to Reuters Health, a spokesperson for the FDA stated that the agency cannot comment on this specific study or the validity of the statements.

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If you have ever experienced painful side effects due to a defective medical device, drug or vaccination, you are not alone. Consumer Reports notes that “tens of millions of Americans live with medical devices implanted in their bodies,” including artificial joints, heart defibrillators and surgical mesh. And while Americans may assume that these devices have been tested for safety and effectiveness, Consumer Reports indicates that this is rarely the case. However, there is a free mobile app that allows you to report any device or drug problems and complaints directly to the FDA.

The MedWatcher app, available in both the Apple iTunes and Google Play stores, is the only app that allows users to track and report negative side effects, obtain recalls, and receive government safety alerts. Users also receive reports of the side effects submitted by other users, thus helping to make medical products safer for everyone.

The FDA encourages healthcare professionals, patients and caregivers “to report serious adverse events that might be associated with a medical device, especially events that are not listed in the product labeling. 'Serious' means fatalities, hospitalizations, and medically significant events.” Reports of therapeutic failures where devices failed to work properly, uncertainties in product names, directions for use or packaging, and other product quality issues such as “suspected counterfeit products, defective components, potential contamination, device malfunctions and poor packaging” are also encouraged to be reported.

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